Description
Release form
Inhalation aerosol.
Packaging
Inhaler with inhalation device contains 200 doses of the drug.
Pharmacological action of
Salbutamol is a selective antagonist of β-2-adrenergic receptors. In therapeutic doses, it acts on β-2-adrenergic receptors of the smooth muscles of the bronchi, exerting a pronounced bronchodilator effect, prevents and relieves bronchospasm, increases the vital capacity of the lungs. Prevents the release of histamine, a slow-reacting substance from mast cells and neutrophil chemotaxis factors. It causes a slight positive chrono- and inotropic effect on the myocardium, the expansion of the coronary arteries, practically does not reduce blood pressure. It has a tocolytic effect: it reduces the tone and contractile activity of the myometrium. The action of the drug begins 5 minutes after inhalation and lasts for 4-6 hours. It has a number of metabolic effects: reduces the content of K + in plasma, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, increases the risk of acidosis.
Indications
prevention and relief of bronchospasm in bronchial asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema.
Contraindications
– Heart rhythm disturbances (paroxysmal tachycardia, polytopic ventricular extrasystole), tachyarrhythmia.
– Myocarditis.
– Heart defects, aortic stenosis.
– Coronary heart disease.
– Thyrotoxicosis.
– Uncompensated diabetes.
– Glaucoma.
– Epilepsy.
– Pyloroduodenal narrowing.
– Liver failure.
– Renal failure.
– Pregnancy.
– Simultaneous administration of non-selective beta-blockers.
– Children under 2 years old.
– Hypersensitivity to any component of the drug.
Precautions prescribe the drug in the following cases:
– Chronic heart failure.
– Hyperthyroidism.
– Arterial hypertension.
– Pheochromocytoma.
Use during pregnancy and lactation
The drug is contraindicated in pregnancy.
Special instructions
In patients with severe or unstable bronchial asthma, the use of bronchodilators should not be the main or only method of therapy. If the effect of the usual dose of Salamol Eco becomes less effective or less prolonged (the effect of the drug should last at least 3 hours), the patient should consult a doctor. Frequent use of salbutamol can lead to increased bronchospasm, sudden death, in connection with which, between doses of the next doses of the drug, it is necessary to take breaks of several hours. The increased need for the use of inhaled -2-adrenoreceptor agonists with a short duration of action to control the symptoms of bronchial asthma indicates an exacerbation of the disease. In such cases, the patient’s treatment plan should be reviewed and the issue of prescribing or increasing the dose of inhaled or systemic glucocorticosteroids (GCS) should be resolved. Therapy with -2-adrenoreceptor agonists can lead to hypokalemia. Particular care is recommended to be taken in the treatment of severe attacks of bronchial asthma, since in these cases hypokalemia may increase as a result of the simultaneous use of xanthine derivatives, corticosteroids, diuretics, as well as due to hypoxia. In such situations, it is necessary to control the level of potassium in the blood serum. Salamol Eco spray can not be punctured, disassembled or thrown into the fire, even if it is empty. Like most other aerosol inhalation products, Salamol Eco may be less effective at low temperatures. When cooling the can, it is recommended to remove it from the plastic case and warm it with your hands for several minutes.
Composition
1 dose of inhalation solution contains: salbutamol sulfate – 124 mcg, which corresponds to a salbutamol content of 100 mcg.
Excipients: hydrofluoroalkane (HFA-134a) – 26.46 mg, ethanol – 3.42 mg.
Dosage and administration
Adults and children over 12 years of age – 100-200 micrograms of salbutamol (1-2 inhalation doses) for stopping asthma attacks.
To control the course of mild asthma – 1-2 doses 1 to 4 times a day and moderate disease severity – in the same dosage in combination with other anti-asthma drugs.
For the prevention of asthma, physical effort – 20-30 minutes before loading 1-2 doses per dose.
For children from 2 to 12 years of age with the development of an attack of bronchial asthma, as well as to prevent attacks of bronchial asthma associated with exposure to an allergen or caused by physical exertion, the recommended dose is 100-200 mcg (1 or 2 inhalations).
The daily dose of salbutamol should not exceed 800 mcg (8 inhalations).
Side effects of the
From the side of the central nervous system: tremor of the hands (a typical side effect for all beta2-adrenergic agonists), headache, dizziness, increased irritability, anxiety, sleep disturbance, insomnia. The drug can cause agitation and increased motor activity in children.
From the cardiovascular system: expansion of peripheral vessels (hyperemia of the skin of the face), a slight compensatory increase in heart rate, increased blood pressure. Arrhythmias are possible (including atrial fibrillation, supraventricular tachycardia and extrasystole).
Allergic reactions: in isolated cases – angioedema, urticaria, erythema, nasal congestion, bronchospasm, arterial hypotension, collapse.
From the digestive system: nausea, vomiting, dyspepsia.
From the respiratory system: paradoxical bronchospasm, irritation of the mucous membrane of the oral cavity and pharynx (pharyngitis), cough.
From the side of metabolism: hypokalemia is possible (can be a serious danger to the patient), reversible hyperglycemia.
Other: muscle cramps.
Drug interaction
Theophylline and other xanthines, when used together with salbutamol, increase the likelihood of developing tachyarrhythmias for inhalation anesthesia, levodopa – severe ventricular arrhythmias. It is not recommended to simultaneously use Salamol Eco and non-selective beta-adrenergic blockers, such as propranolol. Monoamine oxidase inhibitors and tricyclic antidepressants enhance the effects of salbutamol and can lead to a sharp decrease in pressure. Salbutamol enhances the action of central nervous system stimulants, side effects of thyroid hormones, cardiac glycosides. Reduces the effectiveness of antihypertensive drugs, nitrates. Hypokalemia may increase as a result of the simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics. Simultaneous administration with anticholinergics (including inhalation) can increase intraocular pressure.
overdose
Symptoms: nausea, vomiting, increased excitability, hallucinations, tachycardia, flutter of the ventricles, dilation of peripheral blood vessels, decrease in blood pressure, hypoxemia, acidosis, hypokalemia.
Treatment: withdrawal, cardioselective beta-blockers symptomatic therapy. If an overdose is suspected, serum potassium levels should be monitored.
Storage conditions
Do not store above 30 ° C, protecting from direct sunlight.
Shelf life
2 years.
Deystvuyushtee substance
Salybutamol
Terms and conditions
prescription
dosage form
aerosol for inhalation
Teva Pharmaceutical Enterprises Co., Ltd. Israel
